| CTRI Number |
CTRI/2026/01/101460 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study of the effectiveness of rational emotive behavioural therapy on Mobile phone addiction in connection with mental well-being and education in selected higher secondary schools in Kerala |
|
Scientific Title of Study
|
A study of the effectiveness of rational emotive behavioural therapy on Mobile phone addiction in connection with mental well-being and education in selected higher secondary schools in Kerala |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ProfJames Chacko |
| Designation |
THEERTHANKER MAHAVEER UNIVERSITYScholar |
| Affiliation |
THEERTHANKER MAHAVEER UNIVERSITY |
| Address |
THEERTHANKER MAHAVEER UNIVERSITY
COLLEGE OF NURSING
Moradabad U.P
Delhi Road, Moradabad, P.O. Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6282443199 |
| Fax |
|
| Email |
advjameschacko@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.SUMAN VASISHT |
| Designation |
PhD GUIDE |
| Affiliation |
Theerthanker Mahaveer University |
| Address |
Theerthanker Mahaveer University COLLEGE OF NURSING Moradabad, U.P
Delhi Road,Moradabhad P.O Uttarpradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6282443199 |
| Fax |
|
| Email |
advjameschacko@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfJames Chacko |
| Designation |
PhD Scholar |
| Affiliation |
THEERTHANKER MAHAVEER UNIVERSITY |
| Address |
THEERTHANKER MAHAVEER UNIVERSITYMU COLLEGE OF NURSING
Moradabad U.P
Delhi Road,Moradabhad P.O Uttarpradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6282443199 |
| Fax |
|
| Email |
advjameschacko@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ProfJames Chacko |
| Address |
TMU,Delhi Road,Moradabad,U.P |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| JAMES CHACKO |
Kasargod District, |
Higher secondary school,Kasargod
Kerala state
Kasaragod
KERALA |
6282443199
6282443199
Advjameschacko@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,TMU DENTAL COLLEGE AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
good |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | ADOLECENT HIGH SCHOOL STUDENTS | AGE GROUP BETWEEN 16-20 YEARS | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
adolsent higher secondary school students |
|
| ExclusionCriteria |
| Details |
less than 16 years and more than 20 years |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| behavior modification |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [James.scholar@tmu.ac.in].
- For how long will this data be available start date provided 14-04-2026 and end date provided 01-03-2033?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A study of effectiveness of rational immotive behaviour therapy on Mobile phone addiction in connection with mental wellbeing and education in selected higher secondary schools ant kerala The over use of mobile phone andproblems associated with are everywhere around the globe. Adolescents are facing problems in the field of education as a biproduct of this. Inorder to find a solution for this problem,REBT is helpful |